None listed
Conditions
Brief summary
Major depressive disorder ranks second amongst the most important causes of disability in Australia. Anxiety disorders also rank in the top ten causes of disability. One problem is that the benefits of antidepressant medication, the most widely used remedy for both these disorders, are small and the harms are significant. There is a swing towards the use of psychological treatments, of which cognitive behaviour therapy (CBT) is the best researched. However CBT has many out of pocket costs (average >$60 per visit), quality is not assured, and therapy is not widely available outside major city centres. Internet delivered automated cognitive behaviour therapy (iCBT) on the other hand, produces the same benefit and freedom from harms as face to face CBT, but has advantages of low cost, high fidelity and wide distribution at levels comparable to medication. In iCBT studies, however, adherence varies markedly according to the amount of encouragement or clinical guidance provided. In our research, adherence varied from 33% for a group who received no support, to 68% for those who received automated reminders, to 81% for the group who received telephone reminders from a technician. A later comparison of technician reminders with coaching by a clinician showed no difference in adherence or efficacy. The two levels of support were therefore comparable but the costs to the health system were not. The primary purpose of this trial is to examine the efficacy and adherence of iCBT for anxiety and depression (6 lessons + homework + automated reminders) across five varying levels of support plus usual care, compared with usual care alone. Eligible participants will be randomly allocated to one of six groups with varying levels of support: 1) Self-help only; 2) Technician contact upon request; 3) Scheduled technician contact after each lesson; 4) Clinician contact upon request; 5) Scheduled clinician contact after each lesson; or 6) Treatment as usual (TAU) control group. The main hypotheses to be tested are: 1. iCBT at all 5 levels of support will significantly reduce symptoms of anxiety, depression, distress and disability compared to a TAU control group. 2. The efficacy will be related to the frequency of support. 3. The adherence rate will be related to frequency of support. 4. The most cost effective (staff cost per unit of health gain) will be technician support on request. It is hoped that the findings of this trial will provide further information regarding (1) the adherence rates and treatment effects that are associated with various levels of clinician or technician support, (2) the cost effectiveness that is characteristic of each level of intervention, (3) whether certain levels of intervention are not sufficiently effective to be attractive to a health service, and (4) whether there are levels of intervention that are not sufficiently more cost effective than a lower cost intervention to be attractive to a health service.
Interventions
This RCT aims to compare, in people with depression or anxiety or both, the efficacy of an internet-delivered cognitive behavioural therapy (iCBT) with one of five levels of support plus usual care, to usual care alone to establish the superiority over usual care alone and to calculate the cost effectiveness of each level of support.
The iCBT program for depression and anxiety consists of six online lessons representing best practice CBT, as well as regular homework assignments and access to s
This RCT aims to compare, in people with depression or anxiety or both, the efficacy of an internet-delivered cognitive behavioural therapy (iCBT) with one of five levels of support plus usual care, to usual care alone to establish the superiority over usual care alone and to calculate the cost effectiveness of each level of support. The iCBT program for depression and anxiety consists of six online lessons representing best practice CBT, as well as regular homework assignments and access to supplementary resources delivered over the course of 12 weeks. Each lesson was designed using a cartoon narrative and included: psycho-education, behavioral activation, cognitive restructuring, graded exposure, problem solving, assertiveness skills, and relapse prevention. The present study is the first to compare the efficacy and adherence of iCBT for anxiety and depression (6 lessons + homework + automated reminders) with one of five levels of support plus usual care, compared with usual care alone. The six groups are: 1. Self-help only, no personal reminders or contact to these participants 2. Technician contact upon request, participants are able to contact a technician with a query and the technician will possess a script of how to respond to these queries (a lesson by lesson script) 3. Scheduled technician contact after each lesson (6 contacts in total), enquiring how the participant found the lesson and if they have any questions 4. Clinician contact upon request, participants are able to contact a clinician with a query 5. Scheduled clinician contact after each lesson, (6 contacts in total) 6. Usual care control group, after completing three sets of questionnaires, these participants will assess the iCBT program unsupervised (for no cost to the participant) via a secure website ‘Technician’ = health worker ‘Clinician’ = Mental health clinician Usual Care = permission to access GP, use medications and other psychological help for anxiety and depression as desired.
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
People aged over 18 years old who score 10-24 on the PHQ-9 and/or >9 on the GAD-7. Participants must be prepared to provide their name, age, gender, level of education, phone number and information on health service utilisation. Participants are required to have English language skills equivalent to a School Certificate level, access to a phone and a computer with a printer, and must provide electronic informed consent.
Exclusion criteria
People with a self-reported diagnosis of schizophrenia, bipolar disorder, substance dependence and/or taking benzodiazepines on a daily basis; and/or a score of < 9 on the PHQ-9 or GAD-7; of 2 or 3 on Item 9 of the PHQ-9 and/or >24 on the PHQ-9 (i.e. sub-threshold anxiety or depression; very severe depression or frequent suicidal ideation).
Outcome results
None listed